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Performance of an Investigational Blood Glucose Monitoring System in a Clinical Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT01328717
First received: April 1, 2011
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

Subjects with diabetes and study staff used an investigational blood glucose monitoring system.


Condition Intervention
Diabetes
 Device: Contour Link Investigational Blood Glucose Monitoring System

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Trial Protocol for Contour Link System With Contour Sensor

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Bayer HealthCare, Diabetes Care:

Primary Outcome Measures:
  • Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Subjects with diabetes and study staff tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 20% (for reference BG results >=75mg/dL) and within +/- 15mg/dL(for reference BG results <75mg/dL) of the reference method results.


Secondary Outcome Measures:
  • Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation) [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Subjects read User Guide(UG)to learn to use the system and performed meter tasks. Study staff observed, then rated subjects' success (1 to 4) at performing tasks. Scale: 1.Performed tasks correctly without assistance. 2.Performed tasks correctly, but was directed to a specific part of the UG by the study staff as in a Customer Service call. 3.Performed tasks correctly, but required additional review/assistance similar to review of a specific function during a Customer Service call. 4.Subject incorrectly performed part of the testing regimen and was unaware of the error.


Enrollment: 78
Study Start Date: December 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intended Users of the System
Subjects with diabetes used an investigational blood glucose monitoring system.
 Device: Contour Link Investigational Blood Glucose Monitoring System
Subjects with diabetes and study staff each performed Blood Glucose tests from the subject's capillary blood obtained from fingerstick using the Contour Link investigational meter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, 18 years of age and above
  • Diagnosed as having type 1 or type 2 diabetes
  • Currently self-testing blood glucose at home for at least three months
  • Able to speak, read, and understand English
  • Willing to complete all study procedures

Exclusion Criteria:

  • Gestational Diabetes
  • Hemophilia or any other bleeding disorder
  • Employee of competitive medical device company
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328717

Locations
United States, Indiana
Bayer HealthCare LLC, Diabetes Care
Mishawaka, Indiana, United States, 46544
Sponsors and Collaborators
Bayer HealthCare, Diabetes Care
Investigators
Principal Investigator: David Simmons, MD Bayer HealthCare, Diabetes Care
  More Information

No publications provided

Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT01328717     History of Changes
Other Study ID Numbers: R&D-2010-2011.09
Study First Received: April 1, 2011
Results First Received: April 27, 2012
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013